Development
Merck posts first positive Phase III data for TROP2 ADC sacituzumab tirumotecan in endometrial cancer
Merck (NYSE: MRK) reported that sacituzumab tirumotecan endometrial cancer data from the Phase III TroFuse-005 trial met both co-primary endpoints of...
Genentech's Tecentriq gets FDA nod as adjuvant for muscle-invasive bladder cancer treatment
Genentech has secured an atezolizumab bladder cancer FDA approval for the adjuvant treatment of muscle-invasive bladder cancer, with the US FDA clearing...
Candel's genetic therapy set for BLA in prostate cancer after showing 39% improvement in disease-free survival
Candel Therapeutics (Nasdaq: CADL) reported extended follow-up data from its Phase III trial of aglatimagene besadenovec in localized prostate cancer...
Regeneron's fianlimab and cemiplimab combination misses primary endpoint in Phase III melanoma trial
Regeneron Pharmaceuticals (Nasdaq: REGN) reported that its Phase III fianlimab LAG-3 melanoma trial did not meet its primary endpoint, with the combination...
Aardvark hit with FDA clinical hold on TAS2R drug's Phase III Prader-Willi trial
Aardvark Therapeutics (Nasdaq: AARD) announced that the US FDA has placed a full clinical hold on its investigational new drug application for ARD-101,...
Cabaletta Bio's CD19 CAR-Tshows early promise in Phase I/II trial for pemphigus vulgaris
Cabaletta Bio (Nasdaq: CABA) reported early clinical data for rese-cel (resecabtagene autoleucel) administered without preconditioning in pemphigus...
Allterum's anti-CD127 mAb 4A10 enters Phase I for relapsed/refractory acute lymphoblastic leukemia
Allterum Therapeutics is advancing 4A10, a fully human anti-CD127 IgG1 monoclonal antibody licensed from the National Cancer Institute, into a...
Relay Therapeutics' NRAS-selective inhibitor RLY-8161 enters Phase I for NRAS-mutant cancers
Relay Therapeutics launches first-in-human RLY-8161 clinical trial in NRAS-mutant cancers
Chipscreen puts PRMT5 inhibitor into Phase I for MTAP-deleted solid tumors and lymphoma
Chengdu Chipscreen Pharmaceuticals, a subsidiary of Shenzhen-based Chipscreen Biosciences (SSE: 688321), has registered a first-in-human clinical trial for...
Vertex Pharma expands neurology pipeline with first-in-human trial for small-molecule narcolepsy drug
Vertex Pharmaceuticals is advancing VX-433, an oral investigational compound, into a first-in-human Phase I clinical trial targeting narcolepsy type 1, a...
Akeso's ligufalimab shows 80% response rate in Phase II treatment-naïve AML trial
Akeso (HKEX: 9926.HK) reported Phase II data from its ligufalimab AML trial showing an objective response rate of 80.0% versus 66.7% for placebo in...
AstraZeneca's Imfinzi plus Padcev improves survival in muscle-invasive bladder cancer
AstraZeneca (LSE/STO/NYSE: AZN) has reported positive VOLGA trial results in bladder cancer, with perioperative durvalumab (Imfinzi) combined with...
GT Biopharma's B7-H3-targeted NK cell engager enters Phase I testing across solid tumors
GT Biopharma (Nasdaq: GTBP), based in San Francisco, has dosed the first patient in a Phase I basket trial evaluating GTB-5550, a B7-H3-targeted natural...
UroGen's mitomycin shows durable response in Phase III ENVISION bladder cancer trial
Three-year durability data from the ZUSDURI ENVISION trial reinforce the clinical profile of mitomycin (Zusduri) as a non-surgical option for recurrent...
Regenxbio's hits Phase III endpoints with gene therapy for Duchenne muscular dystrophy
Regenxbio (Nasdaq: RGNX), the Rockville, Maryland-based gene therapy company, reported positive topline data from the pivotal Phase III portion of its...
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